Sodium Phenylbutyrate Powder Recalled for Impurity Specification Failures
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source states only that impurity/degradation specifications failed during routine testing, with no reported illnesses or injuries. The hazard is technical noncompliance rather than acute risk of harm, supporting a Moderate severity classification.
Plain-English summary
SigmaPharm Laboratories LLC is recalling Sodium Phenylbutyrate Powder, 250 grams, packaged in 500 cc HDPE bottles with 53 mm CRC caps. The recall affects 1,192 bottles distributed nationwide. The recall was initiated because out-of-specification impurity results were obtained during routine testing, indicating that the product did not meet required impurity and degradation specifications.
The affected lots are: 2005401, 2005501, 2005601, 2005701 (expiration February 2023) and 2101401, 2101501 (expiration February 2024). The product is identified by NDC 42794-086-14.
Patients currently taking this medication should consult their healthcare provider or pharmacist regarding their treatment. Healthcare providers should advise patients not to stop taking their medication without medical guidance, and should work with their pharmacy to obtain replacement medication or appropriate alternatives.
The recalled product
- Product
- Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
- Manufacturer
- SigmaPharm Laboratories LLC
- Category
- Drug — Prescription Powder
- Affected units
- 1,192
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lots 2005401
- 2005501
- 2005601
- 2005701
- Exp FEB 2023
- Lots 2101401
- 2101501
- Exp FEB-2024
Distribution
Distributed nationwide across the United States.
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